Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Set Screw Starter/ Final Driver
Seaspine Orthopedics Corporation
PC2-200011
In Commercial Distribution

  • 10889981199548 ()
PC2-200011

  • Orthopaedic implant driver
Poly. Screwdriver
Seaspine Orthopedics Corporation
PC2-200000
In Commercial Distribution

  • 10889981199432 ()
PC2-200000

  • Surgical screwdriver, reusable
Screwdriver shaft, T25
Inion Oy
1
In Commercial Distribution

  • 06438408008016 ()
IFS-9006

  • Surgical screwdriver, reusable
Screwdriver shaft, T15
Inion Oy
1
In Commercial Distribution

  • 06438408008009 ()
IFS-9005

  • Surgical screwdriver, reusable
Screwdriver shaft, T8
Inion Oy
1
In Commercial Distribution

  • 06438408007996 ()
IFS-9004

  • Surgical screwdriver, reusable
Screwdriver shaft, T7
Inion Oy
1
In Commercial Distribution

  • 06438408007989 ()
IFS-9003

  • Surgical screwdriver, reusable
Applicator 1.5 mm
Inion Oy
2
In Commercial Distribution

  • M224INS928020 ()
  • 06438408007293 ()
INS-9280

  • Bone tack inserter, basic
Screw Driver
Seaspine Orthopedics Corporation
98-1030
In Commercial Distribution

  • 10889981187842 ()
98-1030

  • Surgical screwdriver, reusable
Pin applicator 2.0 mm
Inion Oy
1
In Commercial Distribution

  • M224INS92319 ()
  • 06438408004704 ()
INS-9231

  • Bone tack inserter, basic
Pin applicator 1.5 mm
Inion Oy
1
In Commercial Distribution

  • M224INS92309 ()
  • 06438408004698 ()
INS-9230

  • Bone tack inserter, basic
Applicator 3.2 mm
Inion Oy
1
In Commercial Distribution

  • M224INS92889 ()
  • 06438408004551 ()
INS-9288

  • Bone tack inserter, basic
Applicator 2.7 mm
Inion Oy
1
In Commercial Distribution

  • M224INS92859 ()
  • 06438408004520 ()
INS-9285

  • Bone tack inserter, basic
No Description
Biomet Orthopedics, LLC
905278
In Commercial Distribution

  • 00880304472433 ()
905278

  • Bone tap, reusable
No Description
Biomet Orthopedics, LLC
405898
In Commercial Distribution

  • 00880304469662 ()
405898

  • Surgical screwdriver, reusable
Le Fort Surgical Guide - Wall with Splints - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543494 ()
GCLPFBC

  • Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Slots with Splints - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543487 ()
GCLRFBC

  • Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Slots Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543463 ()
GCLRBC

  • Custom-made orthopaedic/craniofacial surgical guide
Intermediate Orhognathic Surgical Splint
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543449 ()
FICOBC

  • Custom-made orthopaedic/craniofacial surgical guide
2.0 - 3.2 Pin Driver Assembly
Insurgical, Inc.
320-0070-001
In Commercial Distribution

  • 00860007230066 ()
9250022

  • Pin-driving power tool attachment
3.2 - 4.0 Pin Driver Assembly
Insurgical, Inc.
320-0107-001
In Commercial Distribution

  • 00860007230059 ()
9250023

  • Pin-driving power tool attachment
The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subsequent fixation of the osteotomy, with a minimally invasive surgical technique. The MIS Precision Chevron Bunion System™ consists of a single, sterile-packaged SKU that contains both implants and instruments needed for the procedure. The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm. There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire. Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel.
Relja Innovations LLC
RI-2427-C
In Commercial Distribution

  • 00860005968800 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile
EasyShift Repositioning System V3 for 42" wide mattress, compatible with EasyShift Zipper Sheet
Seneca Devices, Inc.
EAS-42-Z
In Commercial Distribution

  • 00860004936817 ()


  • Bed mattress support platform, hydraulic
  • Intensive-care patient transport system, ventilatory support, neonatal
No Description
BUY SUPPLY INC
PG-IRT1602
In Commercial Distribution

  • 00860004330691 ()


  • Infrared patient thermometer, ear
INSTRUMENT 875-090 DSTRACTOR SCREWDRIVER
MEDTRONIC SOFAMOR DANEK, INC.
875-090
In Commercial Distribution

  • 00673978069173 ()


  • Orthopaedic implant driver
INSTRUMENT 873-009 UCS CANN SCREWDRIVER
MEDTRONIC SOFAMOR DANEK, INC.
873-009
In Commercial Distribution

  • 00673978067728 ()


  • Surgical screwdriver, reusable
INSTR 8616021 NUT & SCRWDRVR SHF COLO II
MEDTRONIC SOFAMOR DANEK, INC.
8616021
In Commercial Distribution

  • 00673978064840 ()


  • Orthopaedic implant driver
INSTRUMENT 8616004 SHAFT PEDICULAR SCRDR
MEDTRONIC SOFAMOR DANEK, INC.
8616004
In Commercial Distribution

  • 00673978064673 ()


  • Surgical screwdriver, reusable
INST 8616001 DUALPURPOSE NUTDRVR COLO II
MEDTRONIC SOFAMOR DANEK, INC.
8616001
In Commercial Distribution

  • 00673978064628 ()


  • Orthopaedic implant driver
M8 INST 858-950 5.5 M8 FXD SCDR .25IN
MEDTRONIC SOFAMOR DANEK, INC.
858-950
In Commercial Distribution

  • 00673978063010 ()

  • 5.5mm


  • Surgical screwdriver, reusable
INSTRUMENT 848-929 T25 TRQ LMTING DRVR
MEDTRONIC SOFAMOR DANEK, INC.
848-929
In Commercial Distribution

  • 00673978059143 ()


  • Surgical screwdriver, reusable
INSTRUMENT 848-928 PLG CPTRING T25 DRVR
MEDTRONIC SOFAMOR DANEK, INC.
848-928
In Commercial Distribution

  • 00673978059136 ()


  • Surgical screwdriver, reusable
INSTRUMENT 848-927 SOLID T25 DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
848-927
In Commercial Distribution

  • 00673978059129 ()


  • Surgical screwdriver, reusable
INSTRUMENT 84693E PLUG NUT STARTER
MEDTRONIC SOFAMOR DANEK, INC.
84693E
In Commercial Distribution

  • 00673978058535 ()


  • Orthopaedic implant driver
INSTRUMENT 84692E PLUG DTT STARTER
MEDTRONIC SOFAMOR DANEK, INC.
84692E
In Commercial Distribution

  • 00673978058528 ()


  • Orthopaedic implant driver
INSTRUMENT 84687E PROVSNL PLUG DRVR
MEDTRONIC SOFAMOR DANEK, INC.
84687E
In Commercial Distribution

  • 00673978058498 ()


  • Surgical screwdriver, reusable
INSTRUMENT 84675H T HNDL H REMVL DRVR
MEDTRONIC SOFAMOR DANEK, INC.
84675H
In Commercial Distribution

  • 00673978058313 ()


  • Surgical screwdriver, reusable
INSTRUMENT 84659 CD ILIO SAC SCRWDR CAN
MEDTRONIC SOFAMOR DANEK, INC.
84659
In Commercial Distribution

  • 00673978058238 ()


  • Orthopaedic implant driver
INSTR 836-023 732 SOCKET DRVR SHAFT 3D
MEDTRONIC SOFAMOR DANEK, INC.
836-023
In Commercial Distribution

  • 00673978050546 ()

  • 7/32"


  • Surgical screwdriver, reusable
INSTRUMENT 836-011 QCK CONN RATCHET HNDL
MEDTRONIC SOFAMOR DANEK, INC.
836-011
In Commercial Distribution

  • 00673978050461 ()


  • Surgical screwdriver, reusable
INSTRUMENT 815-518 TORX 25 SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
815-518
In Commercial Distribution

  • 00673978045092 ()

  • T-25


  • Surgical screwdriver, reusable
INSTRUMENT 815-517 TORX 20 SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
815-517
In Commercial Distribution

  • 00673978045085 ()

  • T-20


  • Surgical screwdriver, reusable
INSTRUMENT 815-516 TAPERED HEX SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
815-516
In Commercial Distribution

  • 00673978045078 ()

  • 5mm


  • Surgical screwdriver, reusable
SOCKET DRIVER 808-541 T-HANDLE 7/32 INCH
MEDTRONIC SOFAMOR DANEK, INC.
808-541
In Commercial Distribution

  • 00673978040929 ()

  • 7/32"


  • Surgical screwdriver, reusable
2.0mm x 229mm K-wire
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
WIR2-229
In Commercial Distribution

  • 00856719002237 ()

  • tool/instrument
WIR2-229

  • Manual wire driver
No Description
Moximed, Inc.
1-4039
In Commercial Distribution

  • 00856047005917 ()


  • Orthopaedic surgical procedure kit, non-medicated, single-use
No Description
PRO-DEX, INC.
APD-1000-4
In Commercial Distribution

  • 00856482008436 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
No Description
PRO-DEX, INC.
05.000.030
In Commercial Distribution

  • 00856482008023 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
No Description
PRO-DEX, INC.
APD-BP-001S-1
In Commercial Distribution

  • 00856482008009 ()
  • 10856482008006 ()


  • Disposable battery pack
INSTRUMENT 803-900 HEX HEAD SCREWDRIVER
MEDTRONIC SOFAMOR DANEK, INC.
803-900
In Commercial Distribution

  • 00673978035918 ()


  • Surgical screwdriver, reusable
INSTRUMENT 803-809 RATCHETING THANDLE
MEDTRONIC SOFAMOR DANEK, INC.
803-809
In Commercial Distribution

  • 00673978035888 ()


  • Surgical screwdriver, reusable
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